Universal hepatitis B Vaccination: Is it a Sword of Damocles

[Guest guest]

COMMENTARY -

Hanging Over the Head of the American People?

Burton A. Waisbren, MS, MD, FACP, FASID

INTRODUCTION

" Spontaneous reporting by the alert and competent doctor will, in the

foreseeable future, remain the most important source of new leads about

drugs. " 1

In 1985, a young nurse presented herself with classic early symptoms of a

central nervous system demyelinizing disease. The symptoms started one

month after she received a hepatitis B vaccination.2 Her case reminded me

of a patient I had seen in 1980 who developed a progressive multiple

sclerosis-like disease shortly after he had received a swine flu

vaccination in 1976.3 Surprisingly, I saw two other patients in 1986 and

1987 whose cases almost exactly mirrored that of the young nurse, and in

each instance symptoms started one month after they received a hepatitis B

vaccination.2 In 1988, Shaw et. al. reported on a post-release

surveillance study of hepatitis B vaccine.4 Thirty-eight neurologic

complications that followed hepatitis B vaccination were found in what was

essentially a voluntary reporting system. They discounted most of these

cases by using the dubious rationalization developed by the government to

deny that central nervous system damage had occurred after the swine flu

vaccination.4,5 This rationalization states that if the rate of a

complication reported after a vaccine via a voluntary reporting system is

less than the spontaneous occurrence of that complication as determined by

a 100% reporting system in Olmsted County, Minnesota, then the reported

complication is due to chance.4

Since 1985, many cases have been found in which the hepatitis B vaccines

have been followed by demyelinizing or autoimmune diseases. (Table 1)

These cases, plus the recommendations of the National Ad Hoc Advisory

Committee on Immunization, the Center for Disease Control and Prevention

(CDC), and the American Academy of Pediatrics, that promote the universal

vaccination of infants, have prompted this commentary.5,6,7,8

The thrust of this commentary is not to prove the incidence of occurrence

of adverse effects of this vaccine, nor to denigrate its usefulness in

high-risk patients. It is rather to ask, in view of the above, whether it

is conscionable or wise to administer hepatitis B vaccine to all infants,

with the informed consent suggested by the American Academy of Pediatrics

(which is used by most of the hospitals in the Milwaukee area), which reads

" no serious reactions have been linked to this vaccine. " 5,6

To help the reader answer this question, information will be summarized

with regard to: Why, based on animal studies and experiences with other

vaccines, complications from hepatitis B vaccine should be expected; what

should have been learned from the swine flu vaccine experience; the reports

of damage apparently due to the hepatitis B vaccination; the probable

mechanisms by which hepatitis B vaccine causes neurologic damage; how and

why the push for universal vaccinations came about; and the steps that will

be necessary to address the serious problems posed by this and other future

vaccines.

1. Animal experimentation that should have alerted manufacturers and

government agencies to the dangers of neurologic and autoimmune

complications from hepatitis B vaccine.

Stohlman and Weiner in 1981 showed that the mouse DNA virus JHM causes

acute and chronic demyelination.9 They suggested with supporting data,

that an antibody mediated the chronic disease. This was because during the

course of the disease no active virus was found.

Buchmeir, et al, in 1984 found in their model system of JHM infection in

mice that " antibody response to precisely defined regions on a viral

glucoprotein may induce profound changes in the pathogenesis of the

infection " .10 Dal Canto, et al, in 1982 reviewed experimental models of

virus-induced demyelination.11 They cite the work of Lindsley and others

that demonstrated that a specific MHC class 1 antigen from the host must

coexist in affected animal.12,13 This suggests that the antigenic make up

of the recipient will be a factor in the development of an autoimmune

demyelination.

2. Experiences and authoritative discussions that suggest viruses,

including the hepatitis B virus, can cause demyelination and autoimmunity

in humans and that vaccines have the same propensity. This information

should have forewarned pharmaceutical companies and government agencies

about the demyelinating and autoimmunity dangers of hepatitis B vaccine.

In 1983, Roos reviewed the literature regarding viral diseases that can

cause chronic central nervous system demyelination in humans.14 He stated,

" We know that viruses can cause demyelinating disease in animals " and cited

106 articles to this effect. There is specific information regarding the

relationship of hepatitis B virus itself and the development of a chronic

autoimmune hepatitis.14 In 1975, this fact caused Zuckerman to warn

against assuming that a viral vaccine would not cause a similar reaction.15

Berger, et al's, finding of antibodies to hepatitis B in a case of severe

Guillain-Barre syndrome, an admittedly demyelinating autoimmune disease,

emphasized the importance of this warning since in their case a natural

infection seemed to have set up this autoimmune process.16 An article by

and Stanton in The Quarterly Journal of Medicine in 1954 reviews the

neurological sequelae of prophylactic inoculation up to that time.17 They

cite 144 articles on the subject which, taken as a whole, should leave no

doubt that neurologic complications were a well-recognized complication of

vaccination as early as 1954. Their article is well worth reading if one

has any skepticism regarding the occurrence of severe neurologic

complication after both passive and active immunizations with bacterial or

viral vaccines and antisera. and Stanton's remarks in the

introduction of the paper also seem as relevant today as they were in 1954.

" Finally, it must be admitted that, in the heat of the emotional battle

provoked for and against prophylactic inoculation, there has been a

tendency on the part of the medical profession to turn a blind eye to

unfortunate individual complications of procedures which have indisputable

social value. " 17 One of the most ironic citations in the article is that

of Guillain-Barre who in 1919, reported a fatal case of the syndrome which

now bears their name.18 The patient had received an inoculation of

antiserum. The reader is asked to remember their names because as the

subject has unfolded, the Guillain-Barre syndrome, which will be discussed

in detail in a later section, turns out to be the bellwether or more

serious complication of vaccines.

In 1967, , et al, reported on multiple sclerosis and vaccinations

[19]. They detailed nine cases in which development of or exacerbation of

multiple sclerosis followed a smallpox, yellow fever, tuberculosis and

typhoid vaccination.19 They cited other authors who had reported similar

findings in.20,21,22 They mentioned that there might be a latent period

between the vaccination and the onset of symptoms. One of the explanations

they offered was, " It is possible that the bacterial proteins injected in

the course of the vaccination against typhoid fever and yellow fever may

also belong to the class of intermediate antigens shared by microorganisms

and cerebral white matter. " Thus, we see that the concept now termed

" molecular mimicry, " which will be mentioned later, is based on

pre-existing scientific information.

In 1971, Wells reported in the British Medical Journal, nine cases of

central nervous system disease that followed influenza vaccination.23

In 1973, Rabin, in a letter published in the Journal of the American

Medical Association discussed the problems and politics involved in gaining

recognition of the fact that central nervous system disease can follow

vaccination. He then reported a convincing case of retrobulbar neuritis

that followed influenza vaccination.24

In 1973, , et al, reported a case of severe demyelinization occurring

years after primary smallpox vaccination.25 This report and that of Wells

lend doubt regarding the efficacy of surveillance after viral vaccinations

that only takes into account reactions occurring a few weeks after

vaccination.23,25

In 1974, Bellanti discussed the adverse effects of viral vaccines. In one

division of his paper he discussed adverse effects of viral vaccines which

are seen in normal hosts and which appear to be related to the nature of

the viral antigen.26

In 1980, Owen, et al, reported a case of multiple sclerosis that was

exacerbated after hepatitis. He reviewed reports in the medical

literature, which suggested that nonspecific immune stimulation such as

that caused by virus infections, skin tests and vaccines can cause

exacerbation of demyelinating disease.27

The fact that vaccines and viral infection could be involved in autoimmune

diseases other than those presenting by demyelinization has been brought

out by Keane, et al.28 He reported a case of Richter's syndrome that

followed a typhoid vaccination. Gocke, et al, reported an associated case

of polyarteritis and the Australian antigen.29 A review by Schattner and

Rager?Zisman in 1990 discussed fully the topic of virus-induced

autoimmunity.30

As early as the 1970s specific warnings appeared about the potential

dangers of hepatitis B vaccine and the dangers of relying on a voluntary

reporting of adverse reactions. In 1975, Zuckerman published a paper in

Nature entitled, " Hepatitis B Vaccine: a note of Caution " .15 He noted the

finding of Neurath that antigen determinants related to human plasma are

constituents of hepatitis B surface antigen.31 These antigens are the

active principles of hepatitis vaccines, whether made from serum or by

yeasts. He postulated that anti-immunity evoked by these antigens might

cause the chronicity of hepatitis B. His final statement was to the effect

that studies of hepatitis B vaccine should include careful assessment of

their effects on the immune system. As far as can be determined, this

admonition still has not been followed since there have not been published

studies regarding whether hepatitis B vaccine causes an increase in

antimyelin T-cell clones. These studies, which are easily within the

capabilities of pharmaceutical companies, have not been reported.32

In 1971, Finney, who was the statistician involved in the infamous

thalidomide incident, wrote an article entitled, " Statistical Aspects of

Monitoring for Dangers in Drug Therapy. " 33 This authoritative article

seems to have been ignored entirely by those who set out to promote the

safety of hepatitis B vaccine via epidemiologic methods that relied on

voluntary reporting of toxicity.4 Finney stated that a special United

Kingdom inquiry showed that only 14% of women on the pill who died from

thrombosis or embolism had been reported independently to the committee

responsible for monitoring its safety.33

3. Why the development of the Guillain-Barre syndrome after the swine flu

vaccination in 1976 and 1977 should have forewarned manufacturers and

government agencies about the probable development of central nervous

system demyelination after hepatitis B vaccination.34 How the same

techniques used unsuccessfully to rationalize and deny central nervous

system complications after the swine flu episode are now being used to do

the same thing with reports of central nervous system complications from

the hepatitis B vaccine.4,34

The swine flu vaccine debacle will be discussed in some detail since the

self-serving rationalizations that the government evoked after the event

has been pivotal in the way virus vaccines are promoted to this day.

was the first to report central nervous system demyelination that

occurred after the swine flu injection.35 His statement that, " In some

instances, at least the inducing factor in Guillain-Barre syndrome also

served as the inducing factor in multiple sclerosis " , appears to have been

supported by the additional clinical observations of multiple

sclerosis-type illness that developed after the swine flu vaccination.3,35

I saw and reported five cases of demyelinating disease that occurred after

the swine flu vaccination without knowing of Dr. ' observations.3 By

1982, Dr. and I had personally seen 35 cases of central nervous

system disease that appeared to result from the swine flu injection.36

By this time, the Justice Department, in association with the CDC and the

Public Health Service was faced with a surge of lawsuits claiming

neurologic damage from the swine flu injection. These eventually amounted

to claims of over three billion dollars.37 The claims were against the

United States government because in order to get the pharmaceutical

companies to participate in the swine flu program, a law had been passed in

which the government agreed to assume liability for damage done by the

vaccine.34 The full extent of the swine flu vaccine litigation damage

control program mounted by the government will probably never be known, but

in essence a decision was made to settle complaints of damage due to

Guillain-Barre syndrome and to fight all other complaints in federal

courts. This decision was buttressed by a group of experts that was

impaneled by the government.38 The following assertions were made: Any

complications that occurred more than six weeks after vaccination could not

have been due to the swine flu vaccine: Guillain-Barre syndrome was

rigidly defined in a way that rejected cases that in any way deviated from

that definition; and a distinction was made between the peripheral nerve

damage that admittedly occurred in Guillain-Barre syndrome and any central

nervous system damage. This distinction cannot be justified scientifically

because of the known similarities between myelin of the central nervous

systems and the peripheral nervous system and because of known clinical

associations between the two syndromes.39,40,41

Finally, the government attorneys brought up epidemiology theories that

emanated from the Mayo Clinic which claimed that if the incidence of a

complication was not any higher than occurred in the 100% actuarial system

used in Olmsted County, Minnesota, then the incidence of the complication

occurred by chance. These epidemiologic arguments are patently transparent

knowing that only a small portion of adverse reactions to a drug are

reported.33 Further, their incidence cannot be compared to incidences

derived from a 100% reporting system connected to the Mayo Clinic in a

single county in Minnesota.42 Poser's comment regarding dependence upon

this type of epidemiological statistics to establish causal relationships

are probably most to the point.43,44 He said in 1983, " The dependence upon

epidemiological statistics to establish causal relationships appears to be

a new dimension in our clinicopathological tradition. It sweeps aside the

experience of clinicians and neuropathologists, it denigrates the work of

the experimentalists, and it substitutes calculations of probabilities for

the recognition that variability in the manifestations of disease reflects

the diversity of humanity's genetic attributes. " 43,44. The government

approach to swine flu litigation started to fall apart when Dr. Goldfield

(who first brought the swine flu problem to the attention of the

government) was allowed to see all the case reports of reactions that had

been turned over by the CDC to the Justice Department.45 He found many

cases of central nervous system toxicity that had not been accepted by the

CDC. He reported this fact to an attorney who was suing in a case of

multiple sclerosis. The Justice Department refused to provide these

records and was subsequently sanctioned by Federal Judge Harold Baker as

follows: " The order of the court is that the government is in willful,

deliberate, continuous disobedience to the order of the court for

discovery. This discovery order is relevant on the issue to which the

discovery is directed, that is causation. And the appropriate sanction in

this case is that the issue of causation is taken as decided against the

government. That the swine flu vaccination was a proximate cause of the

nonphysical condition of the plaintiff. " 46 After this sanction the

government settled the case with the promise that the settlement remain

secret. Several other lawsuits of this type were then lost by the

government usually with a federal judge's support.47 The data regarding

how many of the three billion dollars worth of cases are still pending or

were settled would have to be obtained through the Freedom of Information

Act since as in the case, the settlements probably were kept a

secret. However, in a deposition, Dr. Arnason, an expert, who often

testifies for the defense in trials against the government, stated in a

legal deposition that the Justice Department now settles for CNS cases as

well as for the Guillain?Barre syndrome cases following swine flu

vaccination. An example of the types of awards made appeared in the

Medical World News in April 1981. A Federal court awarded Dr.

Wolfe 2.9 million dollars for central nervous system damages caused by the

swine flu vaccine.

The foregoing swine flu incidents are dwelt upon here because both the

Center for Disease Control and Prevention and the manufacturer of hepatitis

B vaccine applied the same reasoning in regard to the cases of toxicity

appearing after the hepatitis B vaccine was released.4 They agreed that

Guillain-Barre disease might occur more frequently than they would expect

in vaccinated populations, but they chose to rationalize the reported cases

of central nervous system diseases and autoimmune diseases as occurring by

chance or that there is no evidence to support causality. Their main

arguments have been that central nervous system complications that were

reported by physicians via the voluntary reporting system represented all

cases that occurred.4 The fallacy of comparing voluntarily reported

complications with those delineated by 100% accurate reporting systems such

as are in place in a single county of Minnesota has been commented upon by

many qualified person.43,44 This type of comparison fails to take into

account Retailliau's authoritative remark to the effect that, " wide spread

underreporting of illness and death in the passive phase of this type of

surveillance system impairs the ability to draw conclusions about reactions

to vaccines from the reports of illness is received " .48 Kaplan admits in a

paper that came from the Center for Disease Control and Prevention that,

" as in any national surveillance system we are aware that not all cases of

Guillain-Barre syndrome diagnosed by participating neurologists are

reported on a case report " .49 This type of comparison also fails to take

into account the authoritative report of Finney which pointed out that

usually only 15% of adverse reactions are voluntarily reported.33

The discussion in this section strongly suggests that when the

Guillain-Barre syndrome turned up as occurring after the hepatitis B

vaccine the swine flu experience should have alerted both pharmaceutical

companies and government agencies to the fact that central nervous system

demyelinization would also turn up. It also points out the fallacy of

rationalizing the central nervous system reports of demyelination by the

same type of reasoning that failed so miserably in the swine flu incident.

4. Reports that have appeared in the literature and in the VAERS (Vaccine

Adverse Experience Reports) reporting system that show that demyelinating

and autoimmune diseases have occurred after the hepatitis B vaccination.

On September 8, 1983, a letter appeared in the New England Journal of

Medicine in which Dr. Ribera and Dr. Dutka of the San Diego Naval Hospital

reported on a case of polyneuropathy that followed a vaccination with

hepatitis B vaccine.50 They stated, " Since inflammatory polyradiculopathy

has occurred after many different types of vaccines, this may be an

interaction of a nonspecific immunologic stimulus with unidentified factors

present in the vaccine. " 50

In March 1985, Snider and Gogate, in a letter to JAMA reported a case of a

possible systemic reaction to hepatitis B vaccine in which there was

polyneuropathy.51 They felt that, " large scale epidemiologic studies are

needed " .

In 1988 Biron, et al, reported a case of myasthenia gravis that occurred

after hepatitis B vaccination.52

In 1988 Shaw, at el, published the results of a postmarketing surveillance

study based on physicians reports of complication due to hepatitis B

vaccine. They used Kurland, et al, as the statistical monitor. They found

even by this generally discredited method of analysis 41 cases in which

hepatitis B vaccinations were followed by serious neurologic adverse

event.4 These events included: convulsions (five cases), Bell's palsy (10

cases), Guillain-Barre syndrome (nine cases), lumbar radiculopathy (five

cases), brachial plexus neuropathy (three cases), optic neuritis (five

cases), and transverse myelitis (four cases).

In 1987, Fried, Conen, Conzelman and Stienemann reported in the Lancet a

case of uveitis that occurred after hepatitis B vaccination.53 They

pointed out that immune complex disease did occur during the natural

hepatitis B infection and that it was reasonable to suppose that this would

happen after vaccination with the same antigen that the patient was exposed

to in the natural infection.54,55

In 1990 the first case of multiple sclerosis that had ever been seen in an

Alaskan child occurred after the 8-year-old child had received hepatitis B

vaccine.56

I saw my first case of chronic severe central nervous system disease that

appeared after a hepatitis B vaccine in 1985.2 I reported this to the

Center for Disease Control and Prevention and to Merck, Sharpe & Dohme, but

it was never acknowledged. A complete case report was turned down for

publication by JAMA. To my surprise I saw a second identical case the next

year and a third case a year later. Case reports of these patients were

not accepted for publication by the Lancet in 1990 or by the Wisconsin

State Medical Journal in 1991. Six months after these rejections, the

Lancet did publish a report by Herroelen and his colleagues in Belgium of 2

cases of demyelination that followed hepatitis B vaccination.57 Dr.

Herroelen by personal communication now states that he has seen over 30

cases with this complication.

In 1992, I was able to share briefly with my colleagues my experiences of

posthepatitis B vaccination which by that time had grown to 6 cases of

bizarre neurologic disease that appeared like atypical multiple sclerosis

which had surfaced in my consultation practice. Only two of these had

presented themselves with any knowledge that hepatitis B vaccine might be

the cause of their illness.

In 1993, Nadler reported a case of multiple sclerosis that followed the

hepatitis B vaccination that was identical to three of the cases I

mentioned in my report.58

By mid-1993, through the Freedom of Information Act, a printout was

obtained regarding adverse neurological reactions that had been reported to

VAERS, the Vaccine Adverse Experience Reports, the agency contracted by the

government to accept adverse reaction reports.59 When this printout was

culled to reject reports that did not seem relevant, there were 257

instances in which reporting physicians had felt an adverse immunological

reaction had taken place. The cases reported to VAERS were broken down as

follows: convulsions (five cases), Bell's palsy (ten cases),

Guillain-Barre (nine cases), lumbar neuropathy (five cases), brachial

plexus neuropathy (three cases), optic neuritis (five cases), and

transverse myelitis (four cases). (Table 1). As a result of my letter to

the Infectious Disease News, I have heard of 5 additional cases of severe

neurologic damage that follow hepatitis B vaccination. They are for the

most part, strikingly similar to the cases I have seen. These cases are

not included on Table 1, which summarizes experiences published for the

most part by VAERS and others.

Table 1 summarizes 310 cases in which professional observers have

concluded that hepatitis B vaccine has caused serious nervous system or

autoimmune complications. If we apply Finney's statistics to this value,

the cases of this type probably run into the thousands since we can expect

to know of only fifteen percent of adverse reactions based simply on

voluntary reporting.33

5. Some of the mechanisms by which hepatitis B vaccine could have caused

both demyelination and autoimmunity.

The first and most likely mechanism through which hepatitis B vaccine

could have caused neurologic damage has been termed molecular mimicry. Put

simply, this concept, which was first named by Damian in 1964, is that

proteins that are presented to the body defenses by either bacteria,

viruses, vaccines or drugs, will evoke an autoimmune reaction if the

polypeptides that constitute their antigenic sites are homologous or almost

homologous to polypeptides present in the body tissue itself.60 In 1980,

Panitch suggested that antibodies to measles and to myelin basic protein

were directed against similar antigenic and other autoimmune diseases.61 A

crucial finding in regard to this being the probable mechanism by which

hepatitis B vaccine caused demyelination were that of of Oldstone and

Fujinami, who showed that the hepatitis B capsular antigen, the antigen in

the hepatitis B vaccine, contained polypeptide sequences that were

homologous or near homologous with myelin.62,63 While the techniques and

computer programs to make these comparisons are readily available, as far

as can be determined polypeptide constituent studies that compare vaccine

polypeptides with those in human myelin have not been undertaken by vaccine

manufacturers.

Another mechanism by which chronic disease could be caused by hepatitis B

vaccine was first suggested with Zuckerman.15 He pointed out that since

much of the pathology induced in hepatitis B infection is mediated by

immunologic mechanisms, that inducing immunity to hepatitis virus had

theoretical risks.

A third mechanism by which hepatitis B vaccine was suggested to cause

chronic disease was reported by Hilleman, the scientist most responsible

for its development.65,66 He states in a discussion regarding the quest

for an AIDS vaccine that, " the message from the hepatitis B example is that

the administration of antigens. . . that directly or indirectly raise

antibodies that attach to host cell receptors may carry large liabilities. "

He suggests that these liabilities may be responsible for a variety of

autoimmune disorders. It is strange that he never mentions this

information in his many discussions regarding hepatitis B vaccine.64,65,66

Hellstrom and her associates have suggested another mechanism by which

hepatitis B vaccine might cause damage. They point out that the pre-S2

antigen (which is in hepatitis B vaccine) may be a pathogenic factor in the

development of chronic autoimmune liver disease that follows hepatitis B

infection and they suggest that it may not be a suitable component of

hepatitis B vaccine.67

The concept that much of hepatitis B vaccine toxicity is due to more

generalized phenomenon that allows autoimmune pathology to be evoked is

suggested by the wide variety of the reported autoimmune reactions that

have been noted after its use. These include multiple sclerosis,

myasthenia gravis, Guillain-Barre syndrome, optic neuritis, encephalitis

and uveitis. (Table 1)

Which of the mechanisms mentioned above causes demyelinating diseases

after vaccination remains to be positively determined. However, the

reasonable theories discussed in this regard should have given pause to

those who claim no serious toxicity has resulted from the vaccine while

they now push for universal vaccination against hepatitis B.5,6,7,8

6. The push for universal hepatitis B vaccination - An " off-label (not

officially accepted by the FDA) use. "

In view of what has been discussed, it is a source of wonderment that

members of the Center for Diseased Control and Prevention, the American

Medical Association, State Medical Societies, the American Academy of

Pediatrics and many other public health agencies have endorsed the idea

that hepatitis B vaccine should be given to every newborn in the United

States.5,6,7,8 How has this come about in spite of the fact that the

Federal Food and Drug Administration has not approved of this use and that

this has to be considered " an off-label use? " An important factor in this

regard is undoubtedly the fact that the market for hepatitis B vaccine can

run into billions of dollars. Merck, Sharpe & Dohme, is said to have sold

240 million dollars worth of this vaccine in 1992.68 Imaginative and

effective promotional methods have been developed by the American

pharmaceutical industry. They have hired scientists who publish articles

in prestigious journals about vaccines, but all too often fail to mention

their dangers. They often fail to mention the authors' connection to the

manufacturer of the vaccine.65,69,70,72 They also hire scientists who just

prior to their employment were in charge of monitoring the safety of their

vaccines regulatory agency as government employees.70 In addition, the

scientists of the Center for Disease Control and Prevention also promote

universal vaccination in articles and appearances before State Medical

Society Committees. For instance, Dr. Harold Margolis of the Center for

Disease Control and Prevention appeared before a committee of the State

Medical Society of Wisconsin in 1992. After his presentation the committee

endorsed universal hepatitis B vaccination of all infants. This was in

spite of the fact that the present vaccines are only approved by the FDA

for use in groups who are at special risk of getting hepatitis B (see

present package insert of hepatitis B vaccine). Does this mean every baby

in the United States regardless of environment or social status is a

special risk for getting hepatitis B? One wonders how many pediatricians

in this country are aware that they are taking the risky step of ordering

an " off label " use of a drug when they allow babies under their care to be

vaccinated. Parents are usually shown the brochure put out by the American

Academy of Pediatrics that states " no serious reactions have been linked to

this vaccine and most children have no associated side effects. " 6 This

brochure patently ignores the information detailed in the preceding section

of this discussion.

Another example of a possibly too-close relationship between the CDC and

industry was the inclusion of Dr. Guess, a statistician with Merck, Sharpe

& Dohme and formerly with the CDC, as the co-author of the paper which

concluded that hepatitis B vaccine did not cause serious CNS neurologic

damage.4

Whether the promotional methods mentioned are ethical and desirable will

have to be decided by the profession and perhaps the courts. In this

connection, The New England Journal of Medicine, have taken an initial step

in this direction by new conflict of interest policies regarding articles

that appear in their journals.72 A recent discussion of this problem in

the distinguished medical journal Science has highlighted the importance

and controversial nature of the " conflict of interest problem " .73

7. What should be done?

In view of the facts presented that show that viruses, and in particular

hepatitis B virus, cause demyelinizing and nervous system damage in both

animals and humans; that these types of damages occur in humans after

administration of the hepatitis B vaccine; that this damage has been

discounted by the manufacturers and government agencies by the use of

questionable and discredited epidemiologic methods, and that there are

several very logical theoretic mechanisms by which this damage could occur,

what can and should be done to meet the problems posed by the vaccine?

First, synthetic vaccines should be developed that evoke resistance to the

target virus but that do not contain any polypeptide sequences present in

human tissue.74 As many as three sequential polypeptides can evoke an

antigenic response as shown by Aw and this should be taken into account.75

Computerized programs can determine these homologies and are readily

available.63 The age of synthetic vaccine production has arrived. The

technology and expertise to produce vaccines devoid of polypeptides

homologous with human tissue are available.76,77,78 Further, meticulous

studies regarding antigenic components that are encephalogenic add another

avenue to screen potentially dangerous antigens from vaccines.

Secondly, modern methods of case finding should be instituted to determine

the rate at which the vaccine causes untoward results. Underreporting

cannot continue to be ignored. The machinery for this critical need was

put into force in the national Childhood Vaccine Injury Act of 1986.79

Hepatitis B vaccine should be included in this governmentally mandated

program for pertussis, measles, mumps and polio. If this is done, complete

records of all that receive the hepatitis B vaccine will be available since

this act requires the administrator of the vaccine to record the name of

all individuals who are vaccinated. With this information a complete

follow-up can be obtained since each person who receives the vaccine can be

contacted as to whether or not it caused immediate or long-term toxicity.

The second provision of the act that states that the government must assume

financial responsibility for untoward vaccine reactions has already proved

unworkable since the money set aside to cover claims was soon exhausted.80

This provision would remove the impetus for pharmaceutical companies to

insure the safety of their own vaccines. If it is utilized in regard to

hepatitis B vaccine, we can expect a replay of the billions of dollars of

claims against the government that resulted from similar swine flu

legislation and which are now occurring with pertussis vaccine.

When the rate of serious vaccine complications has been determined by an

accurate surveillance system the rate at which hepatitis B might be

expected to attack various subgroups of population must be determined.

Surely the risk for a baby from a middle class family must be less than

that for a baby born into the many disastrous situations that occur in many

of our large cities. Then, when individuals can be told the probability of

them getting hepatitis B and the probability of them getting a serious

complication from the vaccine, they can decide whether they or their

children should take the vaccination.

SUMMARY

Specific reasonable suggestions have been made in regard to the problems

that have been discussed. At this point, because of the involvement and

commitment of agencies and manufacturers who appear to have vested interest

in hepatitis B vaccine, these problems might not be fully addressed until

the victims have had their day in court. It is hoped that some remedial

actions can be taken before this occurs.

TABLE 1

NEUROLOGIC AND AUTOIMMUNE DISEASES ATTRIBUTED TO THE HEPATITIS B VACCINATION

AUTHOR REF# COMPLICATIONS NO. OF CASES

Shaw, et al 4 Convulsion 5

Bell's Palsy 10

Guillain-Barre 9

Lumbar Neuropathy 5

Brachial plexus neuropathy 3

Optic Neuritis 5

Transverse Myelitis 4

Ribera 51 Polyneuropathy 1

Snider 52 Polyneuropathy 1

Biron, et al 53 Myasthenia Gravis* 1

Herroelen 58 Demyelination 2

Waisbren 3 Demyelination 5

Nadler 59 Demyelination 1

Fried 54 Uveitis* 1

VAERs up to

Jan, 1993 57 Neuropathy 102

Facial Paralysis 38

Paralysis - note stated 3

Multiple Sclerosis 13

Guillain-Barre 31

Polyneuritis 2

Optic Neuritis 16

Myelitis 12

Peripheral Neuritis 37

Encephalitis 3

____________________________________________________________________

TOTAL 310

*Autoimmune disease

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Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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